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This four center international study will include two United Kingdom National Health Service centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate subject acceptance of a new insulin pump and transmitter together with the accompanying training materials. Descriptive data from participant questionnaires and device uploads will be evaluated.
Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of age upwards, who currently use an insulin pump in the management of their type 1 or type 2 diabetes, will be invited to participate. Each subject will be trained on the study device and then use it for approximately four weeks. During this time there will be three in-clinic visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of this period, they will revert back to their original insulin pump and complete a questionnaire on the study pump training materials, features and usability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic participants with study devices | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed® 640G Insulin Pump and Guardian® Link Transmitter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter | Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance. | Four weeks of pump wear |
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Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the following criteria are met:
Subject is 7 years or older at time of screening
Subject is current insulin pump user for at least 3 months
Subject has the following CGM experience as determined by the Investigator:
Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures;
Subject is willing to complete study questionnaires throughout the study
Must have the following clinical diagnosis:
1. Type 1 diabetes, for a minimum of 6 months prior to enrollment
Criteria for Exclusion: A subject is excluded from the user evaluation if any of the following criteria are met:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent Hospital and The University of Melbourne | Fitzroy | 3050 | Australia | |||
| The Royal Melbourne Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Dependent Diabetics | Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 640G insulin pump and Guardian Link transmitter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Dependent Diabetics | individuals with insulin dependant diabetes using the 640G insulin pump for insulin infusion and continuous glucose monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter | Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance. | Posted | Mean | Standard Deviation | units on a scale | Four weeks of pump wear |
|
October 24, 2014 through November 12, 2014
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | General disorders | Dermatitis contact | Non-systematic Assessment | Allergic reaction to tape |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Medtronic Diabetes | 818-576-5000 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Patkville |
| 3050 |
| Australia |
| University College Hospital | London | NW1 2PG | United Kingdom |
| King's College London | London | SE5 9NU | United Kingdom |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
|
| Nasopharyngitis | Infections and infestations | Nasopharyngitis | Non-systematic Assessment | Common cold |
|
| Urinary tract infection | Infections and infestations | Urinary tract infect | Non-systematic Assessment | Urinary tract infection |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |